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Antidepressant Drug
Claims (Suicide and Birth Defects)
Antidepressant
Drugs can be used to treat people with depression. However, in
pregnant women SSRIs have been linked with birth defects and in
some people, incorrect treatment with certain types of
antidepressant drugs can cause suicidal thinking or actions or
make a depressed person worse. Deciding on whether a person
should be placed on certain types of antidepressants should be a
team decision including the doctor, the patient, and a patient's
parents or guardians if the depressed person is a minor. The
team should discuss all treatment choices, including the
potential dangers of using antidepressants.
If someone you
love has been treated with antidepressants and you believe that
treatment has resulted in suicide or a birth defect, a thorough
investigation should be done. The investigation can determine
if the suicide or birth defect was preventable and was caused by
psychiatric malpractice or other negligence. If it was, steps
should be taken to ensure that this does not happen to anyone
else. If you have any questions about this web page or
investigating an antidepressant claim, feel free to
contact Texas Bad Drug Lawyer Jason Coomer.
Antidepressant Drug SSRI Birth Defect
Claims
Some
medications that have been linked to birth defects include
Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs).
Women that have taken SSRIs after the 20th week of pregnancy
have a 6-fold increased risk of their children developing
persistent pulmonary hypertension, a life-threatening lung
disorder. Infants with
persistent pulmonary hypertension have abnormal blood flow
through the heart and lungs and do not get enough oxygen to
their bodies and may become very sick or die.
The SSRIs antidepressants that have been
linked to persistent pulmonary hypertension (PPHN) include Paxil
by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by
Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor
marketed by Wyeth, Luvox by Solvay, and the generic makers of
these drugs include Barr Pharmaceuticals, Ranbaxy Labs and
Genpharm.
Infants born with PPHN often require
mechanical assistance to breath and even worse about 10% to 20%
of the infants do not survive even when they receive treatment.
The PPHN babies that do survive often experience developmental
delays, brain abnormalities and hearing loss, experts say.
Antidepressant Suicide Drug Claims
The Food and Drug Administration (FDA) has
asked manufacturers of all antidepressant drugs to include in
their labeling a boxed warning and expanded warning statements
that alert health care providers to an increased risk of
suicidality (suicidal thinking and behavior) in children and
adolescents being treated with these agents, and additional
information about the results of pediatric studies. The study
reviewed five selective serotonin reuptake inhibitors (SSRIs) (Celexa,
Prozac, Luvox, Paxil and Zoloft) and four "atypical"
antidepressants (Wellbutrin, Remeron, Serzone and Effexor XR).
Of all antidepressants, only fluoxetine
(brand name: Prozac) has been FDA approved to treat pediatric
depression. For obsessive compulsive disorder, FDA considers
only fluoxetine (brand name: Prozac), sertraline (brand name:
Zoloft), fluvoxamine (no marketed brand name product), and
clomipramine (brand name: Anafranil) to be of proven benefit in
children and teens. The past experiences of the patient with
other treatments or antidepressants may lead the doctor to
suggest other antidepressants than the ones listed above.
However, make sure everyone understands the potential risks of
using antidepressants to treat pediatric depression.
Mirtazapine (marketed as Remeron and Remeron Soltab) have been
linked with suicidal thoughts in adults and teenagers.
Nefazadone hydrochloride (marketed as Serzone
and Nefazodone HCL) is another SSRI that is prescribed for
patients experiencing depression or mental illness. The FDA also
administered a black-box warning for Serzone, claiming it
increased the thoughts and attempts of suicide in children and
adults taking the drug.
Bupropion hydrochloride (marketed as Wellbutrin, Wellbutrin
SR/XL and Zyban) has also drawn the FDA’s attention lately. This
antidepressant is believed to be related to increased thoughts
and attempts of suicide among children and adults taking the
drug.
Additionally, regulatory
authorities in the United Kingdom (U.K.) have announced new
labeling for the antidepressant drug Effexor (venlafaxine) and
antidepressant drugs known as SSRIs (selective serotonin
reuptake inhibitors). For Effexor and the SSRIs, the British
authorities strengthened warnings about
For Effexor, they announced
that patients with heart disease or high blood pressure should
not use the drug. The authorities will only allow certain
physician specialists to prescribe the drug.
Paxil (paroxetine) is one
of a class of medicines called Selective Serotonin Reuptake
Inhibitors (SSRIs). These drugs increase the activity of an
important brain chemical called serotonin, a chemical know to be
deficient in patients with MDD.
The FDA has not approved
Paxil for the treatment of MDD or any other indication in
pediatric patients. However, the FDA does not regulate the
practice of medicine and physicians may use a drug in ways other
than indicated on the labeling when, in their professional
judgment, if it is warranted in a particular case. This is based
on three well-controlled clinical trials carried out in children
(under 18 years of age) with MDD that compared the effect of
Paxil and placebo (sugar pills) and found that Paxil did not
work any better than placebo in the treatment of MDD. In fact,
based on the results of the analyses of safety data from
pediatric studies, it was found that certain suicide-related
behaviors, including suicidal thoughts and attempts, were more
common in children receiving Paxil. The risk of these events in
the study was about 3 times greater with Paxil compared to
placebo. There were no deaths in these trials.
If any of the following behaviors appear for
the first time or seem worse after starting a new antidepressant
medication, a medical professional should be contacted right
away.
New or more thoughts of suicide
Trying to commit suicide
New or worse depression
New or worse anxiety
Feeling very agitated or restless
Panic attacks
Difficulty sleeping (insomnia)
New or worse irritability
Acting aggressive, being angry, or
violent
Acting on dangerous impulses
Being extremely hyperactive in actions
and talking (hypomania or mania)
Other unusual changes in behavior
If someone you love is suffering from
depression, make sure you have all the facts and have carefully
weighed your options prior to selecting an antidepressant. If a
suicide or birth defect has occurred and you believe that it was
caused by an antidepressant, make sure that the birth injury or
suicide is properly investigated. If you have any questions
about this web page or investigating an antidepressant claim,
feel free to
contact Texas Bad Drug Lawyer Jason Coomer. |
